CELLO trial data show efficacy of Excimer laser system

14th May 2008

608

CELLO trial data show efficacy of Excimer laser system.

The six-month data from the CELLO (CLiRpath Excimer Laser System to Enlarge Lumen Openings) clinical trial, presented at the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, DC, has demonstrated the efficacy of TURBO-Booster (Spectranetics) catheter Excimer Laser System. The CELLO study was a prospective, nonrandomised trial designed to provide clinical data on the reduction of arterial blockage in above-the-knee arteries following use of the TURBO-Booster device for the treatment of peripheral artery disease (PAD). The FDAapproved pivotal IDE trial assessed the TURBOBooster catheter in achieving atherectomy when treating larger diameter superficial femoral arteries. TURBO-Booster received clearance from the Food and Drug Administration (FDA) in July 2007 following the conclusion of the trial, which enrolled 65 patients at 17 hospitals in the US. Spectranetics’ TURBO-Booster functions as a guiding catheter facilitating directed ablation of blockages in the main arteries at or above the knee. The TURBO-Booster combined with Spectranetics’ Turbo elite laser catheters allows for removal of large amounts of plaque material within the superficial femoral artery (SFA) and popliteal arteries.Highlights of the data presented include:

·Demonstrated durability of procedure through freedom from target lesion revascularisation in 86% of the patients through six months following the initial procedure;

·No major adverse cardiac events reported through six months following the procedure, which adds to the existing body of clinical evidence supporting the safety of laser ablation; and

·Significant improvement in all clinical outcomes measured six months following the procedure, including Rutherford category, ankle-brachial Index, and walking impairment.

“The six-month data from the CELLO trial demonstrates the ability of laser ablation facilitated by the TURBO-Booster to safely restore blood flow in the superficial femoral artery and significantly improve clinical outcomes in patients with peripheral arterial disease up to six months following the procedure,” said Dr Rajesh Dave, Principal Investigator of the CELLO trial and Chairman, Endovascular Medicine, Pinnacle Health Heart and Vascular Institute at Harrisburg Hospital.“Many patients suffer unnecessarily from pain in the legs and feet that can drastically impact active lifestyles. The TURBO-Booster represents a viable treatment option for those patients with peripheral arterial disease.”

PATENT trial

Spectranetics has enrolled the first patient in the PATENT trial utilising the company’s TURBO elite laser catheters in combination with the recently FDA cleared TURBO-Booster. The PATENT trial is a prospective registry of 100 patients at up to ten sites in Germany. The trial will assess patency as measured by duplex ultrasound at various intervals up to 12 months following the procedure. It will also assess safety as measured by adverse events up to 12 months following the procedure. In the initial procedure performed at the Leipzig Heart Center, four focal lesions were treated successfully with the TURBO-Booster and TURBO elite 2.0mm catheter in a 20cm long stented superficial femoral artery. “The initial result from this Spectranetics device looks very promising, as the new features allow for ablation of more tissue in larger vessels,” said Dr Andrej Schmidt, University of Leipzig-Heart Center. “Instent restenosis in a superficial femoral artery represents one of the most challenging procedures in our practice. The current standard of care, such as repeat balloon angioplasty, does not have good results as these lesions tend to reoccur. We are very excited with the start of this study in Germany, and we look forward to examining the mid- and long-term results of this new therapy.” Separately, the company has received reimbursement approval from the competent governmental authority in Belgium for its lead removal and peripheral atherectomy product line. The reimbursement for the peripheral indication applies to all centers in Belgium equipped with Spectranetics’ technology for patients that suffer from critical limb ischaemia with non-healing ulcers or rest pain due to infrapopliteal disease. Shar Matin, Managing Director of Spectranetics International, commented: “We are very pleased that the Belgian authority granted reimbursement approval for our laser-based therapies. Belgian patients now have greater access to our life-changing technology. Reimbursement initiatives are a cornerstone of Spectranetics International’s strategy and this approval follows the reimbursement approval in Germany for our peripheral atherectomy device earlier this year.”